Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery

NCT03760718 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 19021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The long term objective is to show that intraperitoneal chloroprocaine can be used an alternative option to avoid general anesthesia during cesarean delivery, to alleviate mother's discomfort from surgical pain, reduce complications, and improve the birth experience. The objectives in this study are to determine the amount of chloroprocaine that is absorbed into the blood in order to create a plasma concentration time profile and to determine the incidence of side effects to help guide selection of an appropriate concentration for future study.

Conditions

Cesarean Section

Keywords

chloroprocaine; cesarean delivery; lavage

Outcome Measures

Primary Outcomes (5)

• Chloroprocaine Plasma Concentration at 1 Minute

  The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.

  1 minute after intraperitoneal chloroprocaine administration

• Chloroprocaine Plasma Concentration at 5 Minutes

  The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration.

  5 minutes after intraperitoneal chloroprocaine administration

• Chloroprocaine Plasma Concentration at 10 Minutes

  The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration.

  10 minutes after intraperitoneal chloroprocaine administration

• Chloroprocaine Plasma Concentration at 20 Minutes

  The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration.

  20 minutes after intraperitoneal chloroprocaine administration

• Chloroprocaine Plasma Concentration at 30 Minutes

  The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.

  30 minutes after intraperitoneal chloroprocaine administration

Other Outcomes (3)

• Dizziness

  Within 4 hours of intraperitoneal chloroprocaine administration

• Metallic Taste

  within 4 hours of study drug administration

• Nausea

  Within 4 hours of study drug administration

Study Arms (3)

Preservative free Chloroprocaine Group 1

ACTIVE COMPARATOR

40 ml of preservative-free 1% chloroprocaine

Drug: Preservative free 1% Chloroprocaine

Preservative free Chloroprocaine Group 2

ACTIVE COMPARATOR

40 ml of preservative-free 2% chloroprocaine

Drug: Preservative free 2% Chloroprocaine

Preservative free Chloroprocaine Group 3

ACTIVE COMPARATOR

40 ml of preservative-free 3% chloroprocaine

Drug: Preservative free 3% Chloroprocaine

Interventions

Preservative free 1% Chloroprocaine DRUG

40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.

Also known as: Nesacaine

Preservative free Chloroprocaine Group 1

Preservative free 2% Chloroprocaine DRUG

40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.

Also known as: Nesacaine

Preservative free Chloroprocaine Group 2

Preservative free 3% Chloroprocaine DRUG

40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.

Also known as: Nesacaine

Preservative free Chloroprocaine Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects ≥ 18 to 50 years of age having scheduled cesarean sections on 12C (Labor and Delivery) within Oregon Health \& Science University (OHSU).
• Only subjects having spinal anesthesia will be eligible.
• Only subjects that can have a Pfannenstiel incision will be enrolled.

You may not qualify if:

• Subjects with chronic narcotic usage
• Subjects that are deemed to need a combined spinal epidural for any reason.
• Subjects who are unable to successfully get a spinal block
• Subjects with known atypical cholinesterase activity
• American Society of Anesthesiologist physical status IV or higher
• Subjects with contraindication to neuraxial anesthesia (coagulopathy, infection)
• Subjects with stage 4 chronic kidney disease or worse (eGFR \< 30 ml/min)
• Subjects with significant hepatic dysfunction (AST or ALT \> 2x the upper limit of normal)
• Subjects with allergies to drugs required for this protocol.
• Subjects with multifetal gestations
• Subjects with a BMI \> 40 kg/m2

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU Labor and Delivery; Oregon Health and Science University Hospital

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• Ranney B, Stanage WF. Advantages of local anesthesia for cesarean section. Obstet Gynecol. 1975 Feb;45(2):163-7.

  PMID: 1118089 BACKGROUND

• Togioka BM, Zarnegarnia Y, Bleyle LA, Koop D, Brookfield K, Yanez ND, Treggiari MM. Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery. Anesth Analg. 2022 Oct 1;135(4):777-786. doi: 10.1213/ANE.0000000000006064. Epub 2022 May 11.

  PMID: 35544759 DERIVED

MeSH Terms

Interventions

chloroprocaine

Results Point of Contact

• Title: Brandon Togioka, MD
• Organization: Oregon Health & Science University

togioka@ohsu.edu

503-494-4572

Study Officials

• Brandon M Togioka, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 30, 2018
• Study Start: September 30, 2019
• Primary Completion: September 17, 2020
• Study Completion: December 31, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)